Clinical Trial

Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations

Active, Not Recruiting Phase 1/2
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Summary
BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous system (CNS) activity, and antitumor activity of silevertinib (BDTX-1535). The study population comprises adults with either advanced/metastatic non-small cell lung cancer (NSCLC) with non-classical or acquired epidermal growth factor receptor (EGFR) resistance (EGFR C797S) mutations with or without CNS disease (in Phase 1 and Phase 2), or glioblastoma (GBM) expressing EGFR alterations (Phase 1 only). All patients will self-administer silevertinib (BDTX-1535) monotherapy by mouth in 21-day cycles. Phase 1 enrollment is now complete. Phase 2 is currently ongoing.
Protocol Amendment History 28 amendments
This ClinicalTrials.gov record has been amended 28 times since 2022-02-24; most recent amendment 2026-07-21.
Status change: Recruiting → Active, Not Recruiting 2025-07-09
Status change: Not Yet Recruiting → Recruiting 2022-03-07
Trial Details
NCT Number NCT05256290
Lead Sponsor Black Diamond Therapeutics, Inc.
Conditions Non-Small Cell Lung Cancer, Advanced Non-Small Cell Squamous Lung Cancer, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Lung Cancer, NSCLC, Advanced Lung Carcinoma, Epidermal Growth Factor Receptor C797S, Epidermal Growth Factor Receptor G719X +2 more
Enrollment 200 participants
Start Date 2022-03-31
Primary Completion 2025-11-03 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-22